Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira

NCT ID: NCT02016105

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-02-29

Brief Summary

The aim of the study is to demonstrate equivalent efficacy and similarity in the safety profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type psoriasis.

Detailed Description

The aim of this study (Treatment Period 1) was to demonstrate equivalent efficacy, primarily based on the PASI75 response rate at Week 16, and similar safety of the proposed biosimilar GP2017 and Humira in patients with moderate to severe chronic plaque-type psoriasis at the end of Treatment Period 1, after 17 weeks of study treatment.

The subsequent Treatment Period 2 (Week 17 to Week 35) and the Extension Period (Week 35 to Week 51) were performed to evaluate long-term effects, including immunogenicity (i.e. ADAs), and the effects of repeated switching between GP2017 and Humira.

Conditions

Plaque Type Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GP2017 Adalimumab

Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Group Type: EXPERIMENTAL

GP2017 Adalimumab

Intervention Type: DRUG

Humira ® Adalimumab

Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.

Group Type: ACTIVE_COMPARATOR

Humira ® Adalimumab

Intervention Type: DRUG

Interventions

GP2017 Adalimumab

Intervention Type: DRUG

Humira ® Adalimumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Men or women at least 18 years of age at time of screening
• Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization
• Moderate to severe psoriasis as defined at baseline by:

• PASI score of 12 or greater
• Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 - 4) and,
• Body Surface Area affected by plaque-type psoriasis of 10% or greater
• Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator.

Exclusion Criteria

• Forms of psoriasis other than chronic plaque-type
• Drug-induced psoriasis
• Ongoing use of prohibited psoriasis treatments
• Previous exposure to adalimumab
• Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of treatment with adalimumab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hexal AG

INDUSTRY

Sponsor Role: collaborator

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Total Skin & Beauty Dermatology Center

Birmingham, Alabama, United States

Alliance Dermatology & MOHS Center, PC

Phoenix, Arizona, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Anaheim Clinical Trials

Anaheim, California, United States

Bakersfield Dermatology and Skin Cancer Medical Group

Bakersfield, California, United States

Wallace Medical Group

Beverly Hills, California, United States

California Dermatology & Clinical Research Institute

Encinitas, California, United States

Dr. Howard Sofen

Los Angeles, California, United States

Southern California Permanente Medical Group

Los Angeles, California, United States

Palmtree Clinical Research

Rancho Mirage, California, United States

Medical Center For Clinical Research

San Diego, California, United States

Therapeutics Clinical Research

San Diego, California, United States

Clinical Science Institute

Santa Monica, California, United States

Ventura Clinical Trials

Ventura, California, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Savin Dermatology Center, P.C.

New Haven, Connecticut, United States

Florida Academic Dermatology Center

Coral Gables, Florida, United States

Florida Medical Center & Research Inc

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Psoriasis Treatment Center of South Florida

Pembroke Pines, Florida, United States

McIlwain Medical Group, PA

Tampa, Florida, United States

MedPhase, Inc.

Newnan, Georgia, United States

Pharmaceutical Research Organization

Rigby, Idaho, United States

Dundee Derm.

West Dundee, Illinois, United States

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, United States

The Dermatology Center, PSC

New Albany, Indiana, United States

The Indiana Clinical Trials Center

Plainfield, Indiana, United States

Dermatology Specialists Research, LLC

Louisville, Kentucky, United States

DermResearch, PLLC

Louisville, Kentucky, United States

Pedia Research, LLC

Owensboro, Kentucky, United States

Medical Development Centers, LLC

Baton Rouge, Louisiana, United States

Dermat. & Adv. Aesthetics

Lake Charles, Louisiana, United States

Clinical Trials of America, Inc.

Monroe, Louisiana, United States

Bay State Clinical Trials, Inc.

Watertown, Massachusetts, United States

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Associated Skin Care Specs

Fridley, Minnesota, United States

MediSearch Clinical Trials

Saint Joseph, Missouri, United States

Central Dermatology

St Louis, Missouri, United States

The Clinical Research Center, L.L.C.

St Louis, Missouri, United States

J. Woodson Dermatology & Associates

Henderson, Nevada, United States

Las Vegas Skin and Cancer Clinic

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Buffalo Medical Group, P.C.

Buffalo, New York, United States

Forest Hills Dermatology Group

Forest Hills, New York, United States

New York University Medical

Lake Success, New York, United States

DermResearch Center of New York

Stony Brook, New York, United States

PMG Research of Charlotte, LLC

Charlotte, North Carolina, United States

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, United States

Ohio State University Clinical Trials Management Office

Columbus, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Corvallis Clinic PC

Corvallis, Oregon, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Oregon Medical Research Center, P.C.

Portland, Oregon, United States

University of Pittsburgh Medical Center Health System

Pittsburgh, Pennsylvania, United States

Clinical Partners, LLC

Johnston, Rhode Island, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

PMG Research of Bristol, LLC

Bristol, Tennessee, United States

Austin Dermatology Associates

Austin, Texas, United States

Menter Dermatology Research Institute

Dallas, Texas, United States

Modern Research Associates

Dallas, Texas, United States

Stephen Miller MD

San Antonio, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Advanced Research Institute

Ogden, Utah, United States

Premier Clinical Research

Spokane, Washington, United States

Mountain State Clinical Research

Clarksburg, West Virginia, United States

UMHAT Dr. Georgi Stranski, EAD

Pleven, , Bulgaria

Center for Skin and Venereal Diseases EOOD Sofia

Sofia, , Bulgaria

UMHAT "Alexandrovska", EAD

Sofia, , Bulgaria

Diagnostic-consulting center 3-Varna EOOD

Varna, , Bulgaria

Hopital de l'Archet 2

Nice, , France

Hôpital Charles Nicolle

Rouen, , France

Kozne oddelenie,Nemocnica Kosice-Saca a.s.,1. sukromna nemoc

Kosice-Saca, , Slovakia

Pedi-Derma s.r.o., Dermatovenerologicka ambulancia

Košice, , Slovakia

SANARE s.r.o. Dermatovenerologická ambulancia

Svidník, , Slovakia

SANARE s.r.o.

Svidník, , Slovakia

Countries

United States; Bulgaria; France; Slovakia

References

Lemke L, Blauvelt A, Bruckmann I, Cohen HP, Fan J, Guerrieri D, Horvat M, Poetzl J, Torella C, Wang Q, von Richter O. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. Expert Opin Biol Ther. 2024 Dec;24(12):1375-1385. doi: 10.1080/14712598.2024.2428299. Epub 2024 Nov 19.

Reference Type: DERIVED

PMID: 39545451 (View on PubMed)

Blauvelt A, Leonardi CL, Gaylis N, Jauch-Lembach J, Balfour A, Lemke L, Hachaichi S, Brueckmann I, Festini T, Wiland P. Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS). BioDrugs. 2021 Mar;35(2):229-238. doi: 10.1007/s40259-021-00470-1. Epub 2021 Mar 2.

Reference Type: DERIVED

PMID: 33651341 (View on PubMed)

Other Identifiers

2013-000747-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GP17-301

Identifier Type: -

Identifier Source: org_study_id